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Abiomed Impella RP Flex SmartAssist Recall

Impella RP Flex with SmartAssist. Product Code: 1000323.

Updated January 27, 2026

Abiomed has recalled the Impella RP Flex with SmartAssist heart pump (Product Code 1000323) because a pressure sensor inside the device may malfunction and give inaccurate readings. If the sensor drifts, clinicians may receive false data that could affect treatment decisions for critically ill patients.

Is the Abiomed, Inc. recalled? Yes. This product was recalled by FDA on January 27, 2026. Details below.

What is recalled

Impella RP Flex with SmartAssist heart pump, manufactured by Abiomed, Inc. Product Code: 1000323.

Am I affected

You are affected if you are a patient currently supported by, or a healthcare facility in possession of, an Impella RP Flex with SmartAssist device bearing Product Code 1000323. Check the device label or accompanying documentation for that product code.

What to do right now

This is a Class I recall, the most serious level. If you are a healthcare provider using this device, stop use if clinically safe to do so and contact Abiomed, Inc. directly for guidance. If you are a patient who has received this device, speak with your care team immediately. For further information, visit the FDA recall page at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

The hazard

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Brands affected

Abiomed, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1470-2026
Classification
Class I
Recalled
January 27, 2026
Read the official notice

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